Is your firm looking for ways to efficiently streamline your drug development process? Are you on the lookout for skilled resources who can help you with clinical regulatory services? When you find yourself overwhelmed with all the pressure feeling of handing over your responsibilities to others, given the experience and skill of a clinical trial regulatory service provider, they will help relieve some of that pressure for good.
Flatworld Solutions is a clinical trial regulatory service providing company that uses advanced tools and technologies to deliver the best possible results. Our skilled, knowledgeable team can take care of everything from start to finish by creating, implementing, and monitoring regulatory plans using the latest methods.
Clinical Trial Regulatory Services We Offer
Flatworld Solutions is a leading pioneer in providing exquisite thread pattern trial regulatory services to clients around the globe. Serving as an industry leader when it comes to its primary offering of interest, Flatworld Solutions is proud to offer some of the most experienced and skilled clinical research regulations experts who can understand each client's unique business needs and provide them with services that are specially crafted to their needs. Our team can help you with -
CTA Submission and Consultation
We help you make those submissions a success. We take care of all the necessary non-clinical and clinical study reports for you. We also provide ad-hoc advice regarding CMC and give legal guidance on new regulations which may impact any stage of the clinical program.
Initial CTA Preparation and Management
We help you with checklists about how to prepare country-specific CTAs. With us, you can deal with the regulatory and local authorities throughout your journey of making the right changes to the CTA for different countries participating in your study. We make sure you are prepared with all the step-by-step answers based on your instructions and other applicable guidelines during interactions.
CTA Maintenance Services
We guide you about reviewing the new or updated documentation and answering questions within the documentation. We help through your submission and preparation of non-substantial and substantial amendments to the CTA.
CTA Completion/Closure Services
We help you with the end of trial activities such as managing the preparation and submission of end-of-trial notifications and the study reports, post overviews, and prepare archiving information.
Clinical Trial Regulatory Process We Follow
01. Application for Clinical Trial
We help you process your clinical trial application by ensuring all fields are filled with the relevant information
02. Ethics Committee Review
We send your application to the ethics committee that includes the FDA and IRB. After reviewing the protocol template the application moves to the next stage
03. Pre-assessment Support
We provide pre-assessment support such as enrollment and data collection to keep all concerned authorities up to date
04. Approval and Registration
After the application is approved, we will help you with clinical practice training
Other Services You Can Benefit From
Why Outsource Clinical Trial Regulatory Services to FWS?
Being able to outsource your trial regulatory needs to Flatworld Solutions can be extremely beneficial to you. Here are some of the key factors you should look for when deciding on which company will be your clinical regulatory advisors -
Business owners who come to us want to be proud of their products. They also don't have the cash or time to waste, so we provide them with services that are good quality and affordable.
We sign the HIPAA agreement, so the customer can feel assured that all patient-related data is safeguarded and will not be distributed to secondary entities.
We are an ISMS-certified organization - Information Safety Management System is a procedure of complete information security, verification, and protection. It's assured that all your valuable data will be encrypted and stored in a safe, secure way.
We've got some of the most talented, experienced, and even certified clinical regulatory experts to help make your working experience with us as smooth as possible.
When you choose to partner with us, we will assign a dedicated project manager to you who is the point of contact between your business and the outsourcing company.
Round the Clock Support
Our customer support team is available around the clock to help you get up and running as quickly as possible. You can contact them by phone or email whenever it's convenient for you.
Short Turnaround Time
Our team works with different delivery locations across the globe and is willing to take on any testing that needs to be done quickly and within a truncated timeframe.
We embrace the importance of having good infrastructure and access to high-quality office spaces and the latest clinical regulatory tools and technologies for both you and your company.
ISO certification means that our team ensures that all processes and decisions made as a company align with guidelines laid out for organizations across the globe.
Easily Scalable Services
We have the bandwidth and experience required to increase the size of our team and offer more clinical regulatory services whenever our clients request them.
Client Success Story
FWS Provided Medical Transcription Services to a Team of Australian Radiologists
Our medical transcription team provided high-quality and accurate medical transcription services to a group of radiologists from Australia.
FWS Provided Medical Billing Services to a US-based Firm
We provided end-to-end medical billing services to a medical billing firm based out of Maryland, USA.
Outsource Clinical Trial Regulatory Services to Flatworld Solutions
Thanks, as always, for the AMAZING work! I'm especially impressed at the thyroid ultrasound report with all the TI-RADS scoring, I can't believe you understood all that and typed it so well! You are all incredible. Thanks again.Owner, Diagnostic Care, USA More Testimonials »
Flatworld Solutions has been a leading pioneer in providing exceptional clinical regulatory services, among other kinds of healthcare BPO services to its clients throughout the world. Applying the latest and the most advanced technologies while keeping our extremely sophisticated software systems updated with all our latest discoveries regarding these procedures, we provide the best quality of services.
If you are looking for a reliable and efficient clinical trial regulatory company, then you have come to the right place. Get in touch with us today!
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